Trial Outcomes & Findings for Suturing Distance From the Wound Edge, 2 mm vs 5 mm (NCT NCT03330041)

Last Updated: 2021-05-12

Results Overview

Scale name: Patient Observer Scar Assessment Score. Scale measures six parameters of scars, each using a 10-point scoring system (the six categories are summed to achieve the POSAS score - totals range from 6 to 60), with 1 representing normal skin \& 10 representing the most severe scar imaginable.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

3 months following procedure

Results posted on

2021-05-12

Participant Flow

This randomized clinical trial was conducted at the University of California, Davis dermatology clinic from November 28, 2017, to June 15, 2018.

Participant milestones

Participant milestones
Measure	All Participants A split wound model was used, where half of the wound was repaired with sutures placed 2 millimeters apart and the other half is repaired with sutures placed 5 millimeters apart. A predetermined, concealed randomization number was obtained from the RedCap randomization module, which specified how Side A was treated. Side B was treated the opposite way as A.
Overall Study STARTED	50
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Suturing Distance From the Wound Edge, 2 mm vs 5 mm

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fast Absorbing Gut Suture Placed 2 mm and 5 Mmapart n=50 Participants Wound closed with sutures spaced 2 and 5 millimeters apart will be treated in a simple, interrupted cutaneous suture pattern Fast absorbing gut suture: Fast absorbing surgical gut suture is a strand of collagenous material
Age, Continuous	71.1 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	50 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months following procedure

Outcome measures

Outcome measures
Measure	Fast Absorbing Gut Suture Placed 2 mm Apart n=48 Participants Wound closed with sutures spaced 2 millimeters apart will be treated in a simple, running cuticular suture pattern. Fast absorbing gut suture: Fast absorbing surgical gut suture is a strand of collagenous material.	Fast Absorbing Gut Suture Placed 5 mm Apart n=48 Participants Wound closed with sutures spaced 5 millimeters apart will be treated in a simple, running cuticular suture pattern. Fast absorbing gut suture: Fast absorbing surgical gut suture is a strand of collagenous material.
Patient Posas Score	10.2 score on a scale Standard Deviation 4.7	11.5 score on a scale Standard Deviation 6.4

SECONDARY outcome

Timeframe: 3 months following procedure

A secondary endpoint will include the width of the scar 1 cm from midline on each side. This measurement will be reported in mm

Outcome measures

Outcome measures
Measure	Fast Absorbing Gut Suture Placed 2 mm Apart n=48 Participants Wound closed with sutures spaced 2 millimeters apart will be treated in a simple, running cuticular suture pattern. Fast absorbing gut suture: Fast absorbing surgical gut suture is a strand of collagenous material.	Fast Absorbing Gut Suture Placed 5 mm Apart n=48 Participants Wound closed with sutures spaced 5 millimeters apart will be treated in a simple, running cuticular suture pattern. Fast absorbing gut suture: Fast absorbing surgical gut suture is a strand of collagenous material.
Width of Scar	0.9 mm Standard Deviation 0.6	0.8 mm Standard Deviation 0.4

SECONDARY outcome

Timeframe: 3 months following procedure

If one half of the scar has more associated erythema, this will be noted number of people with erythema after treatment will be reported

Outcome measures

Outcome measures
Measure	Fast Absorbing Gut Suture Placed 2 mm Apart n=48 Participants Wound closed with sutures spaced 2 millimeters apart will be treated in a simple, running cuticular suture pattern. Fast absorbing gut suture: Fast absorbing surgical gut suture is a strand of collagenous material.	Fast Absorbing Gut Suture Placed 5 mm Apart n=48 Participants Wound closed with sutures spaced 5 millimeters apart will be treated in a simple, running cuticular suture pattern. Fast absorbing gut suture: Fast absorbing surgical gut suture is a strand of collagenous material.
Erythema	0 Participants	0 Participants

Adverse Events

Fast Absorbing Gut Suture Placed 2 mm Apart

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fast Absorbing Gut Suture Placed 5 mm Apart

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel Eisen, M.D.

University of California, Davis, Department of Dermatology

Phone: 916-734-6479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place